To explore the safety and efficacy of edaravone dexborneol for patients of acute ischemic stroke received endovascular therapy in extended time windows.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Intravenous injections of edaravone dexborneol (37.5mg in 0·9% NaCl) BID for 7-14days.
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China
RECRUITINGProportion of patients with modified Rankin Score 0 to 3 on day 90
Time frame: 90 days
Proportion of symptomatic intracranial hemorrhage (sICH)
Time frame: 48 hours
mTICI grade (<2 b、≥2 b) stratified for primary outcome analysis
Time frame: 90 days
Changes in National Institute of Health stroke scale (NIHSS) on day 2,7,14
Time frame: 14 days
Distribution of modified Rankin Score after the treatment
Time frame: 90 days
Change in infarct volume
Time frame: 7 days
The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90
Time frame: 90 days
Activity of Daily Living Scale(ADL) score on day 14, 30, 90
Time frame: 90 days
Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90
Time frame: 90 days
Serum inflammatory factors changes on day 1 and day 7
Time frame: 7 days
Proportion of PH1 and PH2 within 48 hours after the treatment
Time frame: 48 hours
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Midline shift on the CT scan
Time frame: 7 days
Proportion of death due to any cause
Time frame: 90 days
Proportion of Serious adverse events(SAE)
Time frame: 90 days